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On December 22, 2016, Turkey adopted a new IP Code of Property no. 6769 IP (IP Code), which repealed and replaced the Decree Laws on Patents and Utility Models, on Trademark and Service Marks, on Industrial Designs, and on Geographical Indications (Decree Law). The new IP Code entered into effect on January 10, 2017. In this multi-part series, we will address how this new IP Code changes the IP landscape in Turkey. In our second installment of the series, we will examine the changes to the codes relating to industrial designs. In part one, we examined the changes to the codes involving patents and utility models.

Submission of the Description of the Designs

Under the new IP Code, during examination, the submission of the description of an industrial design is optional. This is because the information provided in the description does not affect the scope of the protection of the design. In contrast, the former Decree Law required such a description to be provided during examination. The new IP Code avoids an obligatory requirement for registering a design.

Industrial Designs will be Examined for Novelty

During examination, a design will now be examined for“novelty”. Designs found not to be novel will be ex-officio refused. The former Decree Law did not provide an ex-officio novelty search stage during examination. In fact, novelty could only be questioned through a post-grant opposition or an invalidity action before the IP Courts.

Visible Parts of a Complex Product

According to the IP Code, only the visible parts of a complex product are protectable. However, in order for the visible parts of a complex product to be protected, the visible parts must meet novelty and distinctive character requirements. A design is considered to be novel if before the application date no identical design has been made available to the public anywhere in the world.

A design is understood to have an distinctive character if the overall impression it creates on the informed user is significantly different from the overall impression created on the same user by any design which has been made public (in Turkey or anywhere else in the world) before the application date of the design. In the assessment of the distintiveness, the emphasis of the evaluation will be on the common features of the design; however, the degree of freedom of the designer in developing the design will also be taken into consideration.

Spare Parts of a Complex Product

According to Decree Law, the owner of a registered design could not assert its rights with respect to a visible part of a complex product until three years after the time period after which the design was first made available to the public. The new IP Code introduces a new derogation stating that the this three year period is not be applicable if the protected spare part design is mentioned among the list of “equivalent parts” issued by the Ministry of Science, Industry, and Technology.

Shorter Opposition Period

Under the new IP Code, the post grant-opposition period is now three instead of six months. The reduction from six to three months will reduce the total registration time to less than a year.

Non-Registered Industrial Design Rights

In order for a design to be protected as a “non-registered” design, the design must first be made available to the public in Turkey. The duration of protection for a non-registered design is three years from the date the design was first made available to the public (in Turkey). Interestingly, non-registered design protection is intended to protect fast changing designs which are not intended to be registered for long periods by the design owner. This type of protection will avoid registration costs for the designs for which registration is not preferred. However, the owner of a non-registered design will be requested to evidence of ownership and that the design was first made available to the public in Turkey when enforcing its rights.

Non-registered designs are also protectable without any time limit under the unfair competition provisions of the Turkish Code of Commerce which remain in force. During the next few years, it will be interesting to watch whether the Courts in Turkey will still allow such unfair competition cases after the completion of the 3 year protection period.

Enforcement of Non-Registered Designs

Under the new IP Code, designs are protectable for three years from the date of first public disclosure, if such disclosure was made in Turkey. This protection is available for non-registered designs to prevent the use by third parties of identical or similar non-registered designs. The IP Code also provides a common provision for the compensation of damages arising from intellectual property rights including registered and non-registered designs. As a result, a design holder can ask for material damages which include actual damages and loss of income. The loss of income can be calculated pursuant to one of the three (3) options mentioned in the IP Code, namely, the loss of income of the plaintiff, the income of the defendant or in accordance with an exemplary license fee. Upon request by the plaintiff, the Court can increase the damages for the design holder under specific circumstances. Moreover, the design holder can also seek moral/reputational damages.

Under the IP Code, a design holder can ask the Court to issue a preliminary and/or permanent injunction, compensation, the confiscation/destruction of the infringing goods and the tools and machinery (such as those used for manufacturing the infringing products), the publication of the verdict in a daily newspaper or any similar award.

Please continue to watch the BRIC Wall Blog for the remainder of the series on changes to the intellectual property landscape in Turkey.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Okan Can of Deris.

On December 22, 2016, Turkey adopted a new IP Code of Property no. 6769 (IP Code), which repeals and replaces the Decree Laws on Patents and Utility Models, on Trademark and Service Marks, on Industrial Designs, and on Geographical Indications (Decree Law). The new IP Code went into effect on January 10, 2017. In this multi-part series, we will address how this new law changes the IP landscape in Turkey. The first part of the series will focus on changes to the codes regarding Patents and Utility Models.

Post Grant Opposition

Previously, the only way to contest a patent under Turkish Patent Code was to file a cancellation action before the courts. However, under the new IP Code, third party oppositions against granted patents are now possible. Specifically, the opposition must be filed within six months of the publication of a grant decision. Once filed, the patentee is notified of the opposition by the Turkish Patent and Trademark Institute (TPTI), and invited to submit an opinion regarding the opposition or amend its patent (namely, the claims and/or specification). Although the examination board is yet to be established, the board will serve to examine the opposition and patentee’s opinion and amendments, and ultimately decide whether to invalidate the patent or refuse the opposition. The IP Code and the draft of the Regulation on the Implementation of the IP Code, do not stipulate any oral hearing for the opposition proceedings. Third parties may oppose a patent on the grounds that the:

Subject matter of the invention is not novel / does not involve inventive step / is not susceptible of industrial application;

Subject matter of invention is excluded from patentability;

Invention is not disclosed sufficiently clear and complete;

Invention contains subject-matter which extends beyond the content of the application as filed- the subject-matter of the patent is not patentable;

Invention is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art; and

Subject-matter of the patent extends beyond the content of the application as filed.

The examination board will examine the opposition, observations and amendments of the patentee and issue a decision on the revocation/amendment of the patent.

Biotech Patents and Subject Matter Eligible

The provision of the IP Code relating to patentable inventions defines the types of inventions which are not patentable. Specifically, the discovery of any elements of the human body and the human body itself in its natural environment are not patentable. For example, claims directed to human gene sequences or process for cloning a human being will be rejected as being directed to non-patentable subject matter. Unfortunately, claims directed to proteins and antibodies are not specifically addressed. With respect to diagnostic methods, these methods are considered to be non-patentable subject matter in accordance with the European Patent Convention (EPC).

Second Medical Use Patents

The Turkish Supreme Court overruled a 2014 Istanbul IP Court decision which held that the second medical use claims granted by the European Patent Office (EPO) under the European Patent Convention (EPC) 1973 were null and void. The Supreme Court further emphasized that Turkish law does not exclude second medical use inventions from patentability, and acknowledges the protection of second medical use patents validated through the EPC. Unfortunately, the new IP Code is silent with respect to the patentability of second (and further) medical indications of a per se already known substance or composition (second medical use inventions).

Swiss-type claims are not allowable before the EPO for an EP patent application having a filing date or an earliest priority date after 29 January 2011 (G 2/08). However, in practice, the TPTI accepts any type of claims via validation through the EP route without conducting any further examination. Therefore, for effective protection of second medical use patents, it is recommended that applicants proceed through EP validation in Turkey.

Abolition of the Seven-Year Patent System

Under the previous Turkish patent law, a seven year short-term patent could be obtained without an applicant’s having proceeded through substantive examination. The new IP Code mandates that all applicants request substantive examination of their applications. Failure to do so will result in the application being considered to be withdrawn. It is expect that this change will improve the quality of patents and to provide an overall stronger patent framework, particularly for small and medium sized enterprises.

The new IP Code applies to international and national patent applications filed after the enactment of the new IP Code. What this means is that international and national patent applications filed before the enactment of the IP Code will be treated according to the provisions of the Decree Law. It is important to note that should a patentee of a seven year short-term patent wish to convert to a twenty year long term patent through a request of substantive examination, such request will be treated in accordance with the Code in force at the date of the filing of the request.

Utility Model System Re-Adapted

A novelty search will now be required for utility model applications and applicants will have the opportunity to file amendments during the registration proceedings. Although post grant oppositions may be filed against patents, post grant oppositions will not be allowed for utility models. Moreover, the new IP Code stipulates that no utility model certificate will be granted for:

Biotechnological inventions;

Chemical processes or products, or any products or processes obtained therefrom; and

Pharmaceutical processes or products, or any products or processes obtained therefrom.

Employee Inventions System for Universities

Under the new IP Code, any inventions made by scientific staff (including Ph.D. students and non-Ph.D. students) as part of their university employment, belong to the university under certain conditions. This new requirement removes the previous “professor’s privilege”, provided under the Decree Law that provided that researchers and academicians working at universities could automatically own the invention subject to the patent. The new IP Code also states that at least 1/3 of the income generating from use of the patent will belong to the inventor researcher/academician.

Compulsory Licensing

The new IP Code provides new grounds for the granting compulsory licenses. Specifically, the patentee can be requested to grant a compulsory license if the patentee breaches competition such as to block, restrict or destruct the competition in the market. The patentee may also be asked to grant a compulsory license if the use of the patent does not meet the local market needs of the country.

Burden of Proof in Process Patents

Under the previous law, the burden of proof in process patent infringement cases was provided in two Articles. Specifically, the first article, Article 84 of the Decree Law No. 551 stated that where a process patent claimed the manufacture of new products or substances, unless there was proof to the contrary, any product or substance having the same properties (as the product produced by the patented process) were automatically deemed to have been obtained using patented process. Under this situation, the burden of proof was with the person claiming the contrary.

The second article, Article 136, provided that where a process patent claimed the production/preparation of a product, all products possessing the same properties (as the products produced by the patented process) were deemed to have been manufactured by the patented process. A defendant claiming that it manufactured/produced the product without infringing the patented process had the burden of proof.

In the new IP Code, Article 141/2 states that where a process patent claims the production/preparation of a product or a substance, the court may request that the defendant prove that its product (having the same properties as the product produced by the claimed process) has been produced/manufactured without infringing the patented process. Where the patent claims a process for the production/preparation of a new product or substance, all products possessing the same properties as the product produced by the patented process, will be considered to have been produced/manufactured by the patented process. A defendant claiming that it manufactured/produced a product without infringing a patented process will have the burden of proof.

Please continue to watch the BRIC Wall Blog for the remainder of the series on changes to the intellectual property landscape in Turkey.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Okan Can of Deris.

On December 2, 2016, the Delhi High Court struck down Section 24(5) of the Plant Varieties and Farmers Rights Act, 2001 (Act) as unconstitutional in Prabhat Agri Biotech Ltd. et al. v. Registrar of Plant Varieties. As will be discussed in more detail below, the Court held that Section 24(5) violated Section 14 of the Constitution of India. Specifically, the Court held that this section of the Act gave unbridled power to the Register, who was not required to have a legal background or possess any legal expertise, to grant interim relief to a breeder against any abusive third party act occurring during the pendency of an application for registration of a variety.

Background

The Protection of Plant Varieties and Farmers Rights Act, 2001 (Act) was passed in 2001 and went into effect in November 2005. The stated rational of the Act is to establish a system for the protection of plant varieties, rights of farmers and plant breeders as well as encourage the development of new plant varieties in India. Additionally, the Act is intended to provide the protection needed to facilitate the growth of the seed industry in India, ensure the availability of high quality seeds and planting material for farmers as well as protect plant breeders’ rights for accelerated agricultural development within the country.

Section 12 of the Act establishes the Plant Varieties Registry (Registry) to facilitate the registration of varieties while also providing for the appointment of as many registrars (Registrars) as necessary to allow for the registration of such varieties. Section 13 of the Act provides for the maintenance by the Registry of a register called the “National Register of Plant Varieties” (Register). The purpose of the Register is to record the names of all registered plant varieties along with the names and addresses of the respective breeders, the right of such breeders in their registered varieties, the particulars of the denomination of each registered variety, its seed or other propagating material along with specification of the salient features and any other information which may be required for registration of the variety.

Section 2 of the Act provides a number of definitions of key terms that are used throughout the Act. For example, Section 2(za) defines a “variety” as a “plant grouping except a microorganism within a single botanical taxon of the lowest known rank, which can be:

(i) Defined by the expression of the characteristics resulting from a given genotype of that plant grouping;
(ii) Distinguished from any other plant grouping by expression of at least one of said characteristics; and
(iii) Considered as a unit with regard to its suitability for being propagated, which remains unchanged after such propagation,
and includes propagating material of such variety, extant variety, transgenic variety, farmers’ variety and essentially derived variety.”

Section 2(i) defines an “essentially derived variety”. Specifically, this section states that a variety (the initial variety), shall be said to be essentially derived from such initial variety when it:

(i) “is predominantly derived from such initial variety, or from a variety that itself is predominantly derived from such initial variety, while retaining the expression of the essential characteristics that results from the genotype or combination of genotype of such initial variety;
(ii) is clearly distinguishable from such initial variety; and
(iii) conforms (except for the differences which result from the act of derivation) to such initial variety in the expression of the essential characteristics that result from the genotype or combination of genotype of such initial variety.”

Section 2(j) defines “extant variety” as a variety available in India which is:

(i) “notified under section 5 of the Seeds Act, 1966 (54 of 1966); or
(ii) farmers’ variety; or
(iii) a variety about which there is common knowledge; or
(iv) any other variety which is in public domain”.
(v)
Section 2(k) defines “farmer” as any person who:
(i) “cultivates crops by cultivating the land himself; or
(ii) cultivates crops by directly supervising the cultivation of land through any other person; or
(iii) conserves and preserves, severally or jointly, with any person any wild species or traditional varieties or adds value to such wild species or traditional varieties through selection and identification of their useful properties.”

Section 2(l) defines a “farmers’ variety” as a variety which:
(i) “has been traditionally cultivated and evolved by the farmers in their fields; or
(ii) is a wild relative or land race of a variety about which the farmers possess the common knowledge”.

A variety can be registered by submission of an application to the Registrar. According to Section 16 of the Act, an application can be submitted by any “person”. A “person” includes:

(i) any person claiming to be the breeder of the variety; or
(ii) any successor of the breeder of the variety; or
(iii) any person being the assignee of the breeder of the variety in respect of the right to make such application; or
(iv) any farmer or group of farmers or community of farmers claiming to be the breeder of the variety; or
(v) any person authorized in the prescribed manner by a person specified under items (i) – (iv) to make application on his behalf; or
(vi) any university or publicly funded agricultural institution claiming to be the breeder of the variety.

Section 18 describes the specific technical and other information that must be included in each application. According to Section 15, once an application has been submitted, a variety can be registered only if it satisfies the criteria of novelty, distinctiveness, uniformity and stability. During the examination process, the application can be amended if requested by the Registrar. Once an application is accepted, it is published for opposition. If no opposition is filed or if an opposition is rejected, the Registrar will register the variety and issue a certificate. If the certificate issued is for an essentially derived variety, the certificate is valid for nine years from the date of registration for trees and vines and six years from the date of registration for all other plants (which is renewable). However, , the total period of validity of a registration cannot exceed:

(i) eighteen years from the date of registration for trees and vines;
(ii) fifteen years from the date of the notification of that variety by the Central Government under section 5 of the Seeds Act, 1966 (54 of 1966) for extant varieties; and
(iii) fifteen years from the date of registration of a variety in all other cases.

According to Section 28(1) of the Act, a certificate confers an exclusive right on the breeder or his successor, agent or licensee, to produce, sell, market, distribute, import or export the variety. One interesting provision of the Act, which will be discussed in more detail below, is Section 24(5) which gives the Registrar the “power to issue such directions to protect the interests of a breeder against any abusive act committed by any third party during the period between filing of application for registration and decision taken by the Authority on such application”.

Prabhat Agri Biotech Ltd. et al. v. Registrar of Plant Varieties

The petitioners, Prabhat Agri Biotech Ltd. (Prabhat), Nuziveedu Seeds (Nuziveedu) and Kaveri Seed Company Ltd. (Kaveri), challenged the vires of Section 24(5) of the Act. Nuziveedu, a sister company to Prabhat, had, over the course of several years, various hybrid and parental cotton lines copied from one of the respondents, Maharashtra Seeds (Maharashtra). In fact, Maharashtra filed an application to register a hybrid variety of cotton which was alleged to have been developed using Nuziveedu’s proprietary parent lines. After filing its application, Maharashtra filed an application under Section 24(5) against Prabhat and Nuziveedu. The third petitioner, Kaveri, was not subject to an application under Section 24(5) by any third party.

During the proceeding, the Solicitor General, on behalf of the government of India, argued that Section 24(5) was necessary for the public interest. Specifically, the Solicitor General argued that this section of the Act was based on Article 13 of the International Convention for the Protection of New Plant Varieties, 1991 (UPOV), which necessitated Article 24(5) because it obligated parties to take suitable steps to safeguard the rights of applicants during the period during which their application was under evaluation. Specifically, the Solicitor General pointed to the statements in Article 13 of UPOV which states:

“Each Contracting Party shall provide measures designed to safeguard the interest of the breeder during the period between the filing or the publication of the application for the grant of a breeder’s right and the grant of that right. Such measures shall have the effect that the holder of a breeder’s right shall at least be entitled to equitable renumeration from any person who, during the said period, has carried out acts which, once the right is granted, require the breeder’s authorization as provided in Article 14. A Contracting party may provide that the said measures shall only take effect in relation to persons whom the breeders has notified of the filing of the application.”

According to the Solicitor General, Section 24(5) was based on sound public policy due to the fact that Article 13 of UPOV required a measure of interim protection. As a result, Section 24(5) had to be enacted.

In its decision, the Court stated that the power conferred upon the Registrar in Section 24(5), namely, the ability to make an interim order anytime during the pendency of an application, was simply too broad. Specifically, the Court stated:

“…its exercise is not in any manner conditioned upon consideration of any objective material. The only guidance given in the section was that such an order could be made if a person were engaged in an ‘abusive act’”.

According to the Court, an “abusive act” contemplated a range of behaviors from suspicion of infringement or use of someone’s material to the genuine use of material legitimately developed by a rival. As such, the Court stated:

“In other words, ‘abuse’ is not only wide and vague in its import, but ‘abuse’ by which entity – a specified third party, or generically all other parties (consider third parties) in the subject-object verb relationship sharpens the concern that the power (to issue interim orders) is overbroad and without any guidance. To illustrate, an abuse could be a case of theft of variety and its exploitation by sale; if demonstrable, that it is an abuse might be capable of injunctive relief. However, at the other end of the scale, if there is no theft or allegation of theft but rather claim by the applicant that it has developed the variety first and is, therefore, entitled to protection as opposed to the assertion of a rival that such a position is incorrect and the variety is an extant one, or a farmers’ variety, a possible view can be that use by such rival of the variety is an abusive act. Therefore, the basis for grant of an order under the impugned provision is existence of a vague and undefined state of affairs.”

The Court noted that the Act clearly provided the conditions that an applicant had to fulfill to secure the registration of a new variety. In contrast, the Act was less than clear and even vague in terms of what a Registrar had to scrutinize when deciding whether or not to grant interim relief under Section 24(5). What seemed to trouble the Court was the fact that the power of Section 24(5) was exercisable at any stage, even the moment after an application was filed, regardless of the merits of the case (namely, whether the applicant claimed to be a breeder or farmer of even if the variety was entitled to protection).

Additionally, the Court was further troubled by the fact that while the Act clearly spelled out the rights and obligations of the applicants, the qualifications to be fulfilled and the conditions to be made as well as the various steps involved in the granting or refusal of an application, it failed to specify the requirements and/or qualifications of individuals suitable to hold the office of Registrar. In fact, the Court noted that there was nothing in the Act that required that the Registrar have any judicial or quasi judicial expertise. In view thereof, according to the Court, it was constitutionally impermissible to give the Registrar the power to make significant legal determinations such as those contemplated under Section 24(5) given the potentially far-reaching implications.

The Court concluded stating:

“Given the importance of the Act, there is enormous danger in empowering authorities with unguided and uncanalized power through provisions that can implicate livelihoods and limit or impair food access to tens of thousands – potentially hundreds of thousands of farmers and users of plant varieties. The existence of a large section of farmers unschooled in the provisions of the Act and unaware of their rights renders unethical bioprospecting practices and spurious claims to development of new or other registrable varieties, entitled to registration, a real possibility. Section 24(5) of the Protection of Plant Varieties & Farmers’ Rights Act as cast as present may undoubtedly be an adequate remedy to prevent abusive practices (assuming that what is abusive can be defined over a period of time); yet the danger of abuse of the provision itself and the attendant (likely) long term injury to innocent breeders, framers and those in the business of development of hybrids and plant varieties far outweighs its benefits, in view of the unguided nature of the power, which is destructive of the rule of law and contrary to Article 14 of the Constitution of India. Section 24(5) of the Protection of Plant Varieties and Farmers’ Rights Act, 2001, is, therefore, declared void.”

Several fairly significant amendments to Indonesian Patent Law came into effect on August 28, 2016. Some of the key changes include:

Claims directed to second use or second medical use are no longer permitted. This change to Indonesia’s law aligns the country with other countries such as India and Vietnam which also prohibit such claims.

Statement of Ownership. The amendments require the submission of a Statement of Ownership of an invention, signed by the applicant, when filing a patent application. Such a requirement is already in existence for trademarks and industrial designs.

Statements regarding Genetic Resources and Traditional Knowledge. The amendments require that inventions related to and/or derived from genetic resources or traditional knowledge to clearly stipulate in the specification the origin of the genetic resources or traditional knowledge.

Use of patents as fiduciary objects. The amendments allows patents to be used as fiduciary objects (such as a guarantee between a debtor and a creditor). Under the previous law, patents could not be used for such securitization.

Introduction of online filing. Under the amendments, an online filing system will be introduced to allow applicants to file patent applications on the Internet. Previously, applicants had to manually file patent applications at the Directorate General of Intellectual Property’s Office.

Restructuring of the grace period for paying annuities. Under Indonesian patent law, a patent will be considered null and void if annuities are not paid by the requisite due date. However, according to the amendments, an extension of up to 12 months can be requested. Under the previous law, annuities could be paid up to three years from the due date. If annuities were not paid within three consecutive years, the patent would be deemed null and void. Moreover, even if a patent was allowed to lapse due to non-payment of annuities, a Patentee was still obligated to pay the annuities. As a result of the amendments, this obligation to pay outstanding annuities has been eliminated.

Availability of post-grant oppositions. Post-grant oppositions of patents are now available to third parties in addition to pre-grant oppositions.

Expansion of the Appeal Commission Authority. The role of the Patent Appeal Commission (Commission) has been expanded as a result of the amendments. Previously, the Commission only examined appeal petitions of rejected patent applications. Now the Commission has the authority to receive, examine and decide on the appeal petitions of:

A refused application;

A correction of a patent specification, claims, and/or drawings after the application has been granted; and

Notice of a grant decision with respect to a post-grant opposition.

Scope of simple or “petty” patents. The scope of simple patents has been expanded to include new processes or the development of an existing process.

Additional exemptions to patent infringement. Two acts are now specifically excluded from patent infringement. These acts include:

Importation of a pharmaceutical product patented in Indonesia where the product is legally marketed in another jurisdiction without the permission of the patent owner; and

Manufacturing of a pharmaceutical product which is patented in Indonesia within five years before the patent expires, for purposes of licensing and marking after the patent expires (e.g., a “Bolar” exemption).
The exemption regarding importation of a pharmaceutical product described in a) is intended to help ensure that pharmaceutical products are reasonably priced and that access to such products is widened. This exemption can be exercised if it is proven that the price of a certain pharmaceutical product in Indonesia is very high compared to the price in the international market. The exemption is limited to “pharmaceutical products” and does not allow parallel imports of non-pharmaceutical products.

Expansion of the scope of compulsory licenses. Under the new law, a grant of a compulsory license can be made to:

Produce a pharmaceutical product patented in Indonesia for the treatment of a disease;

Import a pharmaceutical product patented in Indonesia that cannot be manufactured in Indonesia presently for purposes of treating a disease; and

Export a pharmaceutical product patented in Indonesia that is manufactured in Indonesia for the purpose of treating an endemic disease (such as upon request by a developing or least developed country).

It has been 13 years since the Brazilian Food and Drug Administration (ANVISA) updated the guidelines regulating which drugs can receive over-the-counter (OTC) status. The much-anticipated guidelines, which issued on August 3, 2016 as Rule #98, revoke the previous Rule #138, which was established in 2003. Rule #138 established which drugs could be sold as OTC medications, according to their therapeutic indications. Drugs currently recognized as safe for over-the-counter use under Rule #138 will continue to be categorized as such until a reassessment can be completed and compliance with Rule #98 evaluated; however the new guidelines allow ANVISA to simultaneously reassess the status of currently available OTC drugs while expanding the number of new products available to consumers.

Rule #98 was previously submitted to Public Inquiry #27 on April 8, 2015. According to ANVISA’s report on the public inquiry, the general feedback was that the new rule will have a positive impact on the market, especially with regards to increasing patient’s access to drugs and the recognition of pharmacists’ roles in healthcare. It is expected that Rule #98 will expand the number of OTC drugs in the Brazilian market, which will increase price competition and marketing efforts towards consumers, rather than physicians.

In order to be compliant with Rule #98, drugs must comply with the following seven criteria:

The drug must have been commercially available for a minimum of 10 years (five years in Brazil), as a prescription drug, or five years, as an OTC drug, in countries where regulations are similar to ANVISA.

The drug must exhibit a high level of safety: the causes of the adverse reactions must be well known and easily reversed, the drug must have a low level of toxicity, a safe therapeutic window, and a low level of interactions with other drugs and food.

The clinical condition treated by the drug cannot evolve rapidly, and its symptoms must be easily identifiable by the consumer.

The drug must pose a low risk when used off label or in overdose scenarios.

The drug cannot be indicated for continuous use; rather, it can only be used for a short period of time or a fixed period of time, which must be identified in the drug’s label (except for drugs labeled for prevention).

The consumer must be capable of using the drug without any physical assistance from a healthcare professional.

The drug cannot cause chemical dependency in consumers.

Companies looking to obtain OTC status for a particular drug can do so at any time; status can be applied for with the Marketing Approval Application, or after the drug has already been approved. The OTC status request must be supported by the required documents listed in Rule #98, ensuring compliance with the above-identified criteria. The company must also support its request with a risk reduction plan, which will inform the ANVISA how it will monitor occasional risks arising from the commercialization of the drug as an OTC product. Once the OTC status is approved, the decision will be published by ANVISA in the Official Gazette and be made available online. The publication will include the active pharmaceutical ingredients (API) in the drug. Once published, companies will have 180 days to make appropriate amendments to the drug packaging and label, as well as have the product sales status changed to OTC.

Importantly, Rule #98 defines which products are not entitled to receive OTC status, which includes drugs that require parenteral administration, or drugs that are commercially packaged, as the quantity of the API per package exceeds the maximum limits established by ANVISA.

The enforcement of Rule #98 will begin 30 days after its publication on September 3, 2016. Please continue to check the BRIC Wall Blog for additional updates on the enforcement of these new guidelines in Brazil.

This is the second update to our 2014 10-part series “The Thorny Problem of Patentable Eligible Subject Matter.” Since that series, the U.S Patent and Trademark Office (USPTO) issued further guidance on December 16, 2014, updated in July 2015 and May 2016 (May 2016 Update), for evaluating subject matter eligibility under Section 101 (Guidance). The new Guidance superseded the March 4, 2014 Guidance. Part 1 – Update on Patentability of Diagnostic Claims: Australia can be found here.

On July 16, 2016, the USPTO issued a memo commenting on recent decisions by the U.S. Supreme Court (Supreme Court) and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in two subject matter eligibility cases directed to life sciences method claims: Sequenom v. Ariosa and Rapid Litigation Management v. CellzDirect, (Rapid Litigation Management) respectively. The memo concludes that neither decision changes the subject matter eligibility framework and that the existing Guidance and training examples are consistent with these cases; however, the memo also notes that the Rapid Litigation Management decision further clarifies the inquiry involved in determining whether a claim is directed to a judicial exception. In particular, the Federal Circuit stated that the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.”

The May 2016 Update provided more detailed instructions for Examiners regarding the formulation of a rejection under Section 101 and evaluation of an Applicants response thereto. Specifically, Examiner’s must identify the exception to patentable subject matter (referred to as a “judicial exception”) that is being claimed, explain what is recited in the claim and why it is an exception, and identify any additional elements that define claim features/limitations/steps that are beyond the exception. The Examiner must then explain why the additional elements individually AND in combination do not result in the claim as a whole amounting to “significantly more” than the exception.

The May 2016 Update also provided additional examples for application of the Guidance to specific types of life science claims, which were not well represented in the December 2014 Guidance.

As discussed in our 2014 series, Article 10 of Brazilian Intellectual Property law (IPL) defines what is not considered to be an invention or a utility model and thus, patent ineligible subject matter. In fact, Article 10 may be considered the counterpart of 35 U.S.C. § 101 in the U.S. According to Article 10, the following are not considered be patent eligible subject matter:

Literary, architectural, artistic, and scientific works or any aesthetic creation;

Computer programs per se;

Presentation of information;

Rules of games;

Operating or surgical techniques and therapeutic or diagnostic methods for use on the human or animal body; and

Natural living beings, in whole or in part, and biological material, including the genome or germplasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes.

Additionally, Article 18 of Brazilian Intellectual Property law further limits what may be patentable and indicates that the following are not patentable:

Anything that is contrary to morals, good customs, and public security, order, and health;

Substances, matter, mixtures, elements or products of any kind, as well as the modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus; and

Living beings, in whole or in part, except transgenic micro-organisms* meeting the three patentability requirements provided for in Article 8 (i.e., novelty, inventive activity, and industrial application) and which are not mere discoveries.

*For the purposes of this law, transgenic micro-organisms are organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that cannot normally be attained by the species under natural conditions.

Additionally, on July 15, 2016, the Ministry of Development, Industry and Foreign Trade, National Institute of Industrial Property (INPI) published Part II of its guidelines for the examination of patent applications relating to patentability (Guidelines). According to Paragraph 1.38 of the Guidelines, a diagnostic method is not considered an invention when the series of steps that comprise the method are applied “in a human or animal body”. Specifically, Paragraph 1.39 states that:

A diagnostic method for application in the human or animal body in accordance with the provisions of item VIII of Article No. 10 of IPL falls within, when it meets the following criteria: (i) it has direct application in the human or animal body, such as, for example, in the base of determining the allergic conditions by diagnostic examination applied in the body, or requires the presence or participation of the patient for its interpretation; and (ii) allows the conclusion of the clinical state of the patient, or indicate various possible clinical states, just based on data processing, analysis or interpretation, information and/or clinical results associated with the patient.

The following is an example provided in the Guidelines of a diagnostic method not considered to be an invention (and hence not patentable):

Automated diagnostic method of a patient, characterized in that it comprises the steps of:

examining the patient to provide at least a first symptom element having a first relative degree of importance to the symptom;

examining the patient to provide at least a second symptom element having a second relative degree of importance to the symptom;

apply the relative degrees of importance for the symptoms, in order to obtain a diagnostics core for the conclusion of a medical condition.

Paragraph 1.41 of the Guidelines makes it clear that methods consisting of in vitro tests that are carried out on blood samples or other tissue removed from the body are considered to be an invention because such tests are not applied to a human or animal body and thus do not “conclude regarding the clinical state of the patient”. However, this same paragraph also notes that diagnostic methods may include a combination of in vivo and in vitro steps. In these instances, “…if the claimed method includes technical steps carried out in vivo, which are inseparable from the in vitro step, the method as a whole will be regarded as being applied on the body and, therefore, it will not be considered invention. In addition, the treatment of tissues, cells or body fluids after they have been removed from the human or animal body, or methods applied onto them, such as methods in vitro, are considered entitled to protection. The methods of measurement of enzymes and blood glucose, complete blood count, serology tests, among others, are included in this case.”

Paragraph 1.42 of the Guidelines further specifies that methods of obtaining information from a human or animal body where the data collected is just an “intermediate result that, by itself, is not enough for defining a diagnosis, are not considered diagnosing methods.” Therefore, such methods are considered to be inventions and thus entitled to protection.

We at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Brazilian patent law for diagnostic method claims based on the May 2016 updated Guidance and Life Science examples.

Analysis of Life Sciences Examples from May 2016 Update to USPTO Guidance

Example 29 – Diagnosing and Treating Julitis

Background: Example 29 of the May 2016 Update relates to a hypothetical situation relating to an autoimmune disease called “Julitis.” An Applicant for a patent discovered that Julitis could be diagnosed by detecting the presence of the hypothetical “JUL-1” protein in patients’ plasma, skin, hair and nails. Applicant has disclosed detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody named “mAb-D33”).

Two representative claims from this Example are analyzed below.

Claim 1. A method of detecting JUL-1 in a patient, said method comprising:

obtaining a plasma sample from a human patient; and

detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

Claim 2. A method of diagnosing julitis in a patient, said method comprising:

obtaining a plasma sample from a human patient;

detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and

diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

Analysis of claims 1 and 2: Both claims 1 and 2 would constitute patent eligible subject matter in Brazil. In the U.S., claim 1 constitutes patent eligible subject matter, while claim 2 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the claim is directed to a judicial exception (i.e., the correlation between the presence of JUL-1 and the presence of julitis in the patient) and as a whole does not amount to significantly more than the exception itself.

Example 31 – Screening for Gene Alterations

Background: Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence of the gene in humans), and has also discovered naturally occurring alterations from the wild-type sequence that are correlated with an increased likelihood of developing breast or ovarian cancer. Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.

At the time the invention was made and the application was filed, scientists routinely compared DNA sequences using two-data generating techniques: (1) hybridizing two different DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detecting whether the molecules bind to each other and form a hybridization product and (2) amplifying (making copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by using a set of primers to produce amplified nucleic acids, and then sequencing the amplified nucleic acids. The probes and primers used in these techniques are short single-stranded DNA molecules that typically have a naturally occurring nucleotide sequence.

In one embodiment, Applicant discloses using a computer-implemented micromechanical method known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe to its target. At the time the invention was made and the application was filed, the use of SNOM to study DNA hybridization had been discussed in several articles in widely-read scientific journals. However, scientists were not commonly or routinely using SNOM to study DNA hybridization at the time the invention was made and the application was filed. Instead, scientists at the time typically used autoradiography to detect hybridization products.

In another embodiment, Applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and annealing temperatures than conventional PCR, which results in Cool-Melt PCR having a 20-fold higher sensitivity of mutation detection than conventional PCR. At the time the invention was made and the application was filed, Cool-Melt PCR was known and used by a few scientists in the field. Several years after filing the application, Cool-Melt PCR became a standard laboratory technique that appeared in virtually every laboratory manual and was conventionally used by most scientists in the field to amplify mutant nucleic acids.

Three representative claims from this Example are analyzed below.

Claim 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids; and

sequencing the amplified nucleic acids.

Analysis of claims 1, 70, and 80: Claims 1, 70, and 80 would constitute patent eligible subject matter in Brazil. In the U.S., claim 1 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the “comparing” amounts to an abstract idea, which is a judicial exception, and the claim as a whole does not amount to significantly more than the exception itself. In contrast, claims 70 and 80 are patent eligible in the U.S., as each claim recites additional elements that distinguishes the claim from well-understood, routine, or conventional techniques in the field (i.e., SNOM and Cool-Melt PCR, respectively), and, therefore, each of claims 70 and 80 as a whole amounts to significantly more than the exception itself.

In view of the above, Brazilian patent law is less restrictive concerning the eligibility of diagnostic method claims as compared to U.S. patent law, at least for the foreseeable future.

This post was written by Lisa L. Mueller and Melissa E. Kolom of Michael Best, and Roberto Rodrigues and Anna Carolina Correa of Licks Attorneys.

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 Report (Report) released on April 12, 2016. Following extensive research and analysis, the Report placed eleven (11) countries on the priority watch list and twenty-three (23) on the watch list. Thailand remains on the Priority Watch List in 2016.

The Report indicates that although steps have been taken to improve IPR protection and enforcement in Thailand, including the launch of the National Intellectual IP Center of Enforcement in 2013 and several legislative measures passed since 2014, these attempts have proven ineffective and unsuccessful. For example, in 2014 the Thai government introduced several amendments to the Customs Act and Copyright Act in an attempt to decrease the volume of illegal goods transiting through the country and to diminish unauthorized cam-cording in Thai theaters. Unfortunately, the government failed to consider concerns expressed by foreign governments on prior drafts of the amendments. As a result, the amendments omitted a much-needed landlord liability provision, failed to provide proper enforcement against unauthorized camcording, and did not set forth adequate protections against the circumvention of technological protection measures (TPMs).

In addition to the above issues, another Copyright Act amendment designed to introduce an option for right holders to obtain a court order to force online service providers to take down infringing content has resulted in a lack of clarity in the operation of the notice-and-takedown procedures. Right holders also express concerns regarding pending legislation imposing content quota restrictions and are concerned about potential unintended effects of pending data and cyber security laws. The Report indicates that it will be critical for Thai authorities to engage closely with foreign governments and industry to ensure that these and future legislative measures effectively improve IPR protection and enforcement in the country.

Other concerns include a backlog in pending patent applications, widespread use of unlicensed software in both the public and private sectors, growing Internet-based copyright piracy, rampant trademark counterfeiting, lengthy civil IPR proceedings and low civil damages, and extensive cable and satellite signal theft. Furthermore, Thailand continues to struggle to provide an effective system for protecting against the unfair commercial use and unauthorized disclosure of data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.

In conclusion, the Report urges Thailand to do more to prioritize IPR enforcement and to address longstanding organizational challenges in the country.

This post was written by Lisa L. Mueller and Rikki A. Hullinger, Ph.D.